StrokeNCT05520034
Reduction of Recurrence of Stroke by Nurse-led Education in Bangladesh
A study testing Health Education in people with Stroke, run by Hiroshima University at 1 site in Bangladesh.
Trial summary
Stroke is a major public issue that can be occurred a patient with severe and unbearable disability for a long time. Recurrence of stroke is increasing due to a lack of knowledge and compliance with treatment regarding the modifiable risk factors of stroke and behavioral and lifestyle changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteBangladesh
- Study dates
- 2 Oct 2022to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Who has stroke with the recurrence
- Stroke subtype: caused by genetic problems or injury/accident
- Patients with multi-organ failure or terminal stage
- Participation in other clinical trials
- Unwillingness to participate in the study
- Not having a mobile phone at home
Show all 10Show fewer
- mRS 5
- Who is not living with the patient
- Who is under 18 years old
- Who is mentally unstable and/or cognitively impaired (diagnosed cases)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
National Institute of Neurosciences & Hospital
Dhaka, 1207
Professor Dr. Sharif Uddin Khan, MBBS, +8801711130273, sharif.911@gmail.com
About this study
Official title: Effectiveness of Health Education Program Among Patients & Family Caregivers on Modifiable Risk Factors mRS 0 to 4 to Reduce Recurrence of Stroke After Discharge From a Tertiary Hospital in Bangladesh
Stroke is a major public issue that can be occurred a patient with severe and unbearable disability for a long time. Recurrence of stroke is increasing due to a lack of knowledge and compliance with treatment regarding the modifiable risk factors of stroke and behavioral and lifestyle changes. Nurse-led health education with (self) monitoring of modifiable risk factors and behaviors can be an effective way to create knowledge about the behavioral changes in stroke patients.
The investigators hypothesized that health education among first stroke patients and their family caregivers could reduce the stroke recurrence rate by controlling modifiable risk factors compared to the first stroke patients without health education.
Read the detailed description
In Bangladesh, the top cause of death per 100,000 population for both sexes aged all ages in 2019 is stroke. About 79.9 percent of the total patients were suffering from ischemic stroke, and 15.7 percent and 4.6 percent were diagnosed with hemorrhagic and subarachnoid hemorrhage respectively. One study found the cumulative recurrence rate was 14.7% at three months, 15.3% at six months, 17.3% at the ninth month, and 20% at one year (n=150).
This study aims to evaluate the effect of health education among first-stroke patients and their family caregivers for reducing the recurrence of stroke. The investigators also assess the number and rate of all adverse events, changes in values of modifiable risk factors, and change scores in knowledge, lifestyle behavior, medication adherence, and QoL.
In this study, participants were the first stroke patients who were discharged from the National Institute of Neurosciences \& Hospital (NINSH) and the family caregivers of the patients. Written informed consent is received from the patient when the patient is the main person of self-management of recurrence prevention, if the patient cannot give consent by disability, his/her family caregiver provided consent.
At baseline, blood specimens such as blood total cholesterol, HDL-cholesterol, HbA1c, and diagnosis including adverse events and blood pressure measurement data were obtained from the hospital records/patient's chart.
At first, the research assistant (RA) nurse should confirm the written consent form for the participants. Then, the RA nurse took the baseline data through the interview. The raw data is stored and locked in secured places in NINSH.
Confidentiality of data is of utmost importance; therefore, every effort is made to safeguard the identity of participants and protect subject privacy. All hard copies of data are stored under lock and kept in the NINSH.
The sample size was based on the calculation of a 10% reduction in recurrence rate compared with the control group with a statistical power of 80% at α= 0.05 (2-tailed). Considering the dropout rate of 10%, the final sample size is 432 (2 arms).
To compare the outcomes of the Intervention Group and Control Group, an intention-to-treat (ITT) analysis and a full analysis set (FAN) were conducted. Descriptive analysis was done to assess the baseline data. For categorical data, the chi-square (X2) test, and for continuous variables, the t-test, or Mann-Whitney U test was employed to compare the two groups where appropriate. For secondary endpoints, after adjusting for confounding variables such as age, an analysis of covariance (ANCOVA) was used to assess the effect of the intervention on the outcomes. To compensate for missing data, the last observation carried forward was measured. The significance level will be set at P=0.05. Data will be analyzed using SPSS (version 26.0; IBM Corp).
In 5% of the study participants, the quality control team independently checked the collected data on the same day using a field-tested methodology. Detected errors were corrected immediately at the field site. The findings of the quality control team are considered for necessary corrections if any major discrepancies are found.
- Conditions
- Stroke
- Being tested
- Health Education
- Keywords
- Stroke, Caregiver, Recurrence of stroke, Health education, Bangladesh
- Medical subject headings
- Stroke, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
The participants received a 45mins, face-to-face group health education after enrollment and during the 6th month by a RA nurse. Participants received the same health education over the phone call if the patient and family caregiver could not come for any reason. They also received a digital BP machine, a salt-measurement spoon, a medication box, and a recording notebook for monitoring. The intervention group receives health education above and reminder telephone calls provided by research assistant nurses every month (1st month to 3rd month: twice a month, and 4th month to 12th month: once a month)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The participants provided health education regarding understanding stroke and the risk factors, lifestyle changes related to modifiable factors, (self)-monitoring of daily blood pressure (BP), and compliance with medication and hospital/clinic visits. At 6 and 12 months RA nurses collected data and samples for lab tests from the patient's house if the patient cannot come to NINSH for any reason. We provided all the patients with lab test costs and transportation fees if they visited any healthcare center for any lab test related to our study. Receives: Behavioral: Health Education |
| Control Group | No intervention | The participants received a one-time telephone call from research nurses every month to keep in contact (telephone calls did not include health education). At 6 and 12 months RA nurses collected data and samples for lab tests from the patient's house if the patient cannot come to NINSH for any reason. We provided all the patients with lab test costs and transportation fees if they visited any healthcare center for any lab test related to our study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the recurrence rate of stroke.
Compare the recurrence rate of stroke between the intervention group and the control group
Measured: 12 months
Secondary outcomes (8)
Change of the number of adverse events
Compare the number of all causes of death, and cardiovascular events between the intervention group and the control group. The adverse event refers that all cases that need to be diagnosed: for example, new onset of acute myocardial infarction (AMI) and unstable angina, heart failure (with hospitalization), PAD (peripheral arterial disease: hospitalization)
Measured: 12 months
Change in values of blood pressure level
Compare value of blood pressure (mmHg) between the intervention group and the control group.
Measured: 12 months
Change in value of HbA1c
Compare value of HbA1c (%) between the intervention group and the control group.
Measured: 12 months
Change in non-HDL cholesterol
Compare value of non-HDL cholesterol (mg/dl) (total cholesterol minus HDL cholesterol) between the intervention group and the control group.
Measured: 12 months
Changes in scores in knowledge related to stroke
Compare scores in knowledge related to stroke (the researcher-developed "Knowledge questionnaire of stroke") between the intervention group and the control group. The questionnaire consists of 10 items with "No/Wrong answer", "Yes/Correct answer", and "Don't know" answers. The score ranges from 0-20, and a higher score indicates having better knowledge.
Measured: 12 months
Changes in scores in lifestyle behavior related to stroke
Compare scores in lifestyle behavior related to stroke (the researcher-developed "Lifestyle behavior questionnaire related to stroke") between the intervention group and the control group. The questionnaire consists of 14 items (6 items will not be counted) with a Likert scale with the frequency of behaviors. The score ranges from 0-37, and a higher score indicates having better lifestyle behavior.
Measured: 12 months
Changes in scores in medication adherence
Compare scores of behavior changes in medication adherence measured by a "Medication adherence related questionnaire" between the intervention group and the control group.
The questionnaire consists of 4 items with "Yes=0" and "No=1" answers. The score ranges from 0-4, and a higher score indicates better compliance.
Measured: 12 months
Changes in scores in QoL
Compare behavior changes in QoL measured by a "WHOQOL- BREF Bangla Version-2 items)" between the intervention group and the control group. Each item scores from 1 (very poor/very dissatisfied) to 5 (very good/very satisfied), and ranges (mean of 2 items) from 1 to 5, a higher mean indicates a better QoL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start2 Oct 2022
- Primary completion28 Feb 2024
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial (RCT) study
- Masking
- None (open label)
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neuro Sciences & Hospital, Bangladesh
- Responsible party
- Principal investigator, Mahabuba Afrin, Hiroshima University
- Investigators
- KATM Ehsanul Huq, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520034
- Sponsor's protocol ID
- 151
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clarke DJ, Forster A. Improving post-stroke recovery: the role of the multidisciplinary health care team. J Multidiscip Healthc. 2015 Sep 22;8:433-42. doi: 10.2147/JMDH.S68764. eCollection 2015.
PubMed 26445548Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
PubMed 29791947GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PubMed 34487721Afrin M, Huq KATME, Khan SU, Das SC, Chowdhury MSJH, Fukuoka Y, Fukushima Y, Moriyama M. Effectiveness of a Health Education Program to Reduce Recurrence of Stroke by Controlling Modifiable Risk Factors in a Specialized Hospital in Bangladesh: Randomized Controlled Trial. JMIR Public Health Surveill. 2025 May 27;11:e72233. doi: 10.2196/72233.
PubMed 40424617Afrin M, Khan SU, Das SC, Huq KATME, Moriyama M. Effectiveness of a Health Education Program for Patients Who Had a Stroke and Their Caregivers by Controlling Modifiable Risk Factors to Reduce Stroke Recurrence in a Tertiary Hospital in Bangladesh: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 15;12:e51178. doi: 10.2196/51178.
PubMed 38100172
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Education Program Among Patients & Family Caregivers on Modifiable Risk Factors mRS 0 to 4 to Reduce Recurrence of Stroke After Discharge From a Tertiary Hospital in Bangladesh
- ClinicalTrials.gov ID
- NCT05520034
- Acronym / sponsor ID
- 151
- Conditions
- Stroke
- Keywords
- Stroke, Caregiver, Recurrence of stroke, Health education, Bangladesh
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neuro Sciences & Hospital, Bangladesh
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is a major public issue that can be occurred a patient with severe and unbearable disability for a long time. Recurrence of stroke is increasing due to a lack of knowledge and compliance with treatment regarding the modifiable risk factors of stroke and behavioral and lifestyle changes. Nurse-led health education with (self) monitoring of modifiable risk factors and behaviors can be an effective way to create knowledge about the behavioral changes in stroke patients.
The investigators hypothesized that health education among first stroke patients and their family caregivers could reduce the stroke recurrence rate by controlling modifiable risk factors compared to the first stroke patients without health education.
Detailed description
In Bangladesh, the top cause of death per 100,000 population for both sexes aged all ages in 2019 is stroke. About 79.9 percent of the total patients were suffering from ischemic stroke, and 15.7 percent and 4.6 percent were diagnosed with hemorrhagic and subarachnoid hemorrhage respectively. One study found the cumulative recurrence rate was 14.7% at three months, 15.3% at six months, 17.3% at the ninth month, and 20% at one year (n=150).
This study aims to evaluate the effect of health education among first-stroke patients and their family caregivers for reducing the recurrence of stroke. The investigators also assess the number and rate of all adverse events, changes in values of modifiable risk factors, and change scores in knowledge, lifestyle behavior, medication adherence, and QoL.
In this study, participants were the first stroke patients who were discharged from the National Institute of Neurosciences \& Hospital (NINSH) and the family caregivers of the patients. Written informed consent is received from the patient when the patient is the main person of self-management of recurrence prevention, if the patient cannot give consent by disability, his/her family caregiver provided consent.
At baseline, blood specimens such as blood total cholesterol, HDL-cholesterol, HbA1c, and diagnosis including adverse events and blood pressure measurement data were obtained from the hospital records/patient's chart.
At first, the research assistant (RA) nurse should confirm the written consent form for the participants. Then, the RA nurse took the baseline data through the interview. The raw data is stored and locked in secured places in NINSH.
Confidentiality of data is of utmost importance; therefore, every effort is made to safeguard the identity of participants and protect subject privacy. All hard copies of data are stored under lock and kept in the NINSH.
The sample size was based on the calculation of a 10% reduction in recurrence rate compared with the control group with a statistical power of 80% at α= 0.05 (2-tailed). Considering the dropout rate of 10%, the final sample size is 432 (2 arms).
To compare the outcomes of the Intervention Group and Control Group, an intention-to-treat (ITT) analysis and a full analysis set (FAN) were conducted. Descriptive analysis was done to assess the baseline data. For categorical data, the chi-square (X2) test, and for continuous variables, the t-test, or Mann-Whitney U test was employed to compare the two groups where appropriate. For secondary endpoints, after adjusting for confounding variables such as age, an analysis of covariance (ANCOVA) was used to assess the effect of the intervention on the outcomes. To compensate for missing data, the last observation carried forward was measured. The significance level will be set at P=0.05. Data will be analyzed using SPSS (version 26.0; IBM Corp).
In 5% of the study participants, the quality control team independently checked the collected data on the same day using a field-tested methodology. Detected errors were corrected immediately at the field site. The findings of the quality control team are considered for necessary corrections if any major discrepancies are found.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial (RCT) study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health EducationThe participants provided health education regarding understanding stroke and the risk factors, lifestyle changes related to modifiable factors, (self)-monitoring of daily blood pressure (BP), and compliance with medication and hospital/clinic visits. At 6 and 12 months RA nurses collected data and samples for lab tests from the patient's house if the patient cannot come to NINSH for any reason. We provided all the patients with lab test costs and transportation fees if they visited any healthcare center for any lab test related to our study. |
| Control Group | No intervention | –The participants received a one-time telephone call from research nurses every month to keep in contact (telephone calls did not include health education). At 6 and 12 months RA nurses collected data and samples for lab tests from the patient's house if the patient cannot come to NINSH for any reason. We provided all the patients with lab test costs and transportation fees if they visited any healthcare center for any lab test related to our study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Who has stroke with the recurrence
- Stroke subtype: caused by genetic problems or injury/accident
- Patients with multi-organ failure or terminal stage
- Participation in other clinical trials
- Unwillingness to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationThe participants received a 45mins, face-to-face group health education after enrollment and during the 6th month by a RA nurse. Participants received the same health education over the phone call if the patient and family caregiver could not come for any reason. They also received a digital BP machine, a salt-measurement spoon, a medication box, and a recording notebook for monitoring. The intervention group receives health education above and reminder telephone calls provided by research assistant nurses every month (1st month to 3rd month: twice a month, and 4th month to 12th month: once a month) | Behavioural | Intervention group |
Primary outcome
Change of the recurrence rate of stroke.
Time frame: 12 months
Compare the recurrence rate of stroke between the intervention group and the control group
8 secondary outcomes
Change of the number of adverse events
Time frame: 12 months
Change in values of blood pressure level
Time frame: 12 months
Change in value of HbA1c
Time frame: 12 months
Change in non-HDL cholesterol
Time frame: 12 months
Changes in scores in knowledge related to stroke
Time frame: 12 months
Changes in scores in lifestyle behavior related to stroke
Time frame: 12 months
Changes in scores in medication adherence
Time frame: 12 months
Changes in scores in QoL
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 26445548Clarke DJ, Forster A. Improving post-stroke recovery: the role of the multidisciplinary health care team. J Multidiscip Healthc. 2015 Sep 22;8:433-42. doi: 10.2147/JMDH.S68764. eCollection 2015.
- Background: PubMed 29791947Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
- Background: PubMed 34487721GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Derived from this study: PubMed 40424617Afrin M, Huq KATME, Khan SU, Das SC, Chowdhury MSJH, Fukuoka Y, Fukushima Y, Moriyama M. Effectiveness of a Health Education Program to Reduce Recurrence of Stroke by Controlling Modifiable Risk Factors in a Specialized Hospital in Bangladesh: Randomized Controlled Trial. JMIR Public Health Surveill. 2025 May 27;11:e72233. doi: 10.2196/72233.
- Derived from this study: PubMed 38100172Afrin M, Khan SU, Das SC, Huq KATME, Moriyama M. Effectiveness of a Health Education Program for Patients Who Had a Stroke and Their Caregivers by Controlling Modifiable Risk Factors to Reduce Stroke Recurrence in a Tertiary Hospital in Bangladesh: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 15;12:e51178. doi: 10.2196/51178.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KATM Ehsanul Huq, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education in people with Stroke, run by Hiroshima University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahabuba Afrin, PhD (+8108057903018, mahabuba.a32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the recurrence rate of stroke. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05520034, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.